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FDA 510(k)

HAEMATURIA CATHETERS

K-Number: K841511 · 1984-07-12

ApplicantWarne Surgical Products, Ltd.
Decision Date1984-07-12
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HAEMATURIA CATHETERS is the device name listed in this FDA 510(k) record. The listed applicant is Warne Surgical Products, Ltd.. It received FDA 510(k) clearance on 1984-07-12 under 510(k) number K841511. The device is classified under product code KOD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HAEMATURIA CATHETERS?

HAEMATURIA CATHETERS is a medical device that received FDA 510(k) clearance on 1984-07-12. The listed applicant is Warne Surgical Products, Ltd.. The 510(k) number is K841511.

When did HAEMATURIA CATHETERS receive FDA 510(k) clearance?

HAEMATURIA CATHETERS received FDA 510(k) clearance on 1984-07-12, under 510(k) number K841511.

Who is the listed applicant for HAEMATURIA CATHETERS?

The FDA 510(k) record lists Warne Surgical Products, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HAEMATURIA CATHETERS?

The FDA product code for HAEMATURIA CATHETERS is KOD.

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Other records listing Warne Surgical Products, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K850694WSP CODE 4310 STRESSCATHK850696WSP CODE 4300 DIOMASTER DIAGNOSTICK850695WSP CODE 4301 DIOMASTER THERAPEUTICK850693WSP CODE 4315 PADTESTK840687KIDNEY TRANSPLANT CATHETERK841410BUSH NECK W/TAP

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Related Devices (Code: KOD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251864Rubber Utility CatheterC.R. Bard, Inc.K220036Wellead Ureteral CatheterWell Lead Medical Co., Ltd.K220730allFlex Ureteral Catheters, Krait Ureteral CathetersAllwin Medical Devices, Inc.K211032Urinary Catheter 12 Fr, Urinary Catheter 16 FrUrogen Pharma, Ltd.K181979Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent CatheterTeleflexmedical, Inc.K180354UroGen Ureteral CatheterUrogen Pharma, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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